Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)

July 28, 2021 updated by: Jan-Markus Dörr, Charite University, Berlin, Germany

Phase II Study of Efficacy of Vitamin D Supplementation in Multiple Sclerosis

Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple Sclerosis (MS).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany
        • Neurologische Praxis
      • Berlin, Germany
        • Neurologisches Facharztzentrum
      • Halle, Germany
        • Krankenhaus Martha-Maria Halle-Dölau gGmbH
      • Potsdam, Germany
        • Sankt Josefs Krankenhaus Potsdam Neurologie
    • Brandenburg
      • Teupitz, Brandenburg, Germany
        • Kliniken für Neurologie Teupitz/Lübben, Asklepios Fachkliniken Brandenburg GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent
  • Age between 18 and 65 at randomization
  • Relapsing-remitting MS according to the revised McDonald-Criteria (2005)
  • EDSS ≤ 6,0
  • Stable immunomodulatory treatment for at least 3 months
  • Sufficient birth control (Pearl-Index <1) and negative pregnancy test at screening/randomization

Exclusion Criteria:

  • Any other MS-course than RRMS
  • Treatment with high dose vitamin D within 6 months prior to randomization
  • Patients who have received over the last three months prior to randomization, an immunomodulatory therapy with the exception of IFN-β1b (Betaferon ®)
  • Any condition that could interfere with MRI or other study related investigation
  • Intolerability to Gd-DTPA
  • Hypersensitivity to the drug Colecalciferol
  • Patients with sarcoidosis
  • Presence or history of nephrolithiasis
  • Pseudohypoparathyroidism

  • Clinically relevant dysfunction of liver, bone narrow or kidney defined by the following laboratory values:

    • HB <8.5 g / dl
    • WBC <2.5 / nl
    • platelet count <100/nl
    • Creatinine clearance by Cockcroft-Gault formula: Cl <110ml/min (male) and Cl <95ml/min (female)
    • AST / ALT> 3.5 times higher than the upper reference value
    • bilirubin> 2.0 mg / dl
    • hypercalcaemia> 2.7 mmol / l
    • calcium / creatinine ratio in urine> 1
  • Treatment with hydrochlorothiazide, digitoxin, digoxin, phenytoin, barbiturates
  • Pregnancy or lactation period
  • Participation in any clinical study within 3 months before or at any time during study
  • Any medical, psychiatric or other condition that could interfere with the patient's ability to understand and give the informed consent, to comply with the protocol or to finish the study any ruling commitment or placement in an institution

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Verum (high dose)
verum arm receiving high dose Vitamin D oil
Drug: Verum arm receiving Vitamin D oil
oil: 20000 IU/g tablet: 400 IU/g every second day
Experimental: Verum (low dose)
low dose arm receiving neutral oil and low dose of Vitamin D
Drug: low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day
neutral oil and a low dose of vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy parameters
Time Frame: 1 day
efficacy of Vitamin D (high dose) in patients with Multiple Sclerosis compared to low dose of Vitamin D
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety & tolerability parameters
Time Frame: 1 day
Routine laboratory, vital signs, physical examination, ECG, AE reporting, Quality of Life
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

NeuroCure Clinical Research Center, Charite, Berlin

Investigators

  • Study Director: Jan-Markus Dörr, Dr., Charité
  • Principal Investigator: Jan-Markus Dörr, Dr., Charite-NeuroCure

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

September 19, 2011

First Submitted That Met QC Criteria

September 23, 2011

First Posted (Estimate)

September 26, 2011

Study Record Updates

Last Update Posted (Actual)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVIDIMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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